QC Specialist

Job description

Our QC Specialist supports Phase 1 GMP testing laboratory for release and stability for multiple stages of our cell and gene therapy products. This includes performing analytical methods, data review and trending, supporting continuous improvement of GMP systems to ensure a compliant Quality Control lab. They interface with Analytical Development and Method Validation ensuring successful method transfer, Quality Assurance, IT, Facilities, and other cross-functional teams as required. They have a cGMP operational and technical background in cell biology, biochemistry and/or molecular biology. As a QC Specialist, a typical day may include: Perform cGMP analytical testing (bioassay, cell culture, flow cytometry, qPCR, ELISA) Review and evaluate raw data (peer review level) Author SOPs/FORMs and technical reports with guidance Initiate laboratory deviations and support investigations (IA, OOS, AR) performing assessment, authoring protocols/ reports and investigation closure with guidance Author, review and execute equipment validations with guidance Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data inte...